Cleared Traditional

K872866 - STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE)

K872866 is an FDA 510(k) clearance for STAND. CLEAR VINYL DISPOSABLE ECG ELECT..., manufactured by Labeltape Meditect, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K872866 · Labeltape Meditect, Inc. · Cardiovascular device
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Jan 1988
Decision
191d
Days
Class 2
Risk

K872866 is an FDA 510(k) clearance for the STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE). Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Labeltape Meditect, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on January 28, 1988 after a review of 191 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Labeltape Meditect, Inc. devices

FDA 510(k) Submission Details - K872866

510(k) Number K872866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1987
Decision Date January 28, 1988
Days to Decision 191 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 125d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 181
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K872866.
BARD TAB ECG MONITORING ELECTRODE
K890103 · C.R. Bard, Inc. · Jan 1989
BARD MULTI-TAC ECG MONITORING ELECTRODE
K884064 · C.R. Bard, Inc. · Oct 1988
SYNCOR (R) MODEL S-801 ECG ELECTRODE
K882216 · Lectec Corp. · Jul 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A
K874421 · Hewlett-Packard Co. · Jan 1988
PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D
K874422 · Hewlett-Packard Co. · Jan 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E
K874423 · Hewlett-Packard Co. · Jan 1988